Protecting Kidneys Through a Low Protein Diet: A Stepwise Multiple-Choice System Approach
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: low protein diet.
- Who it may be relevant to
- Registry conditions: Chronic Kidney Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Nephrology care continues to progress and recommendations are now focused on delaying as much as possible the need for renal replacement therapy ("intent-to-defer"strategy). Protein restriction is a valuable tool for stabilizing chronic kidney disease (CKD) and retarding the need for renal replacement therapy, but the best diet to be prescribed is still matter of discussion. This study is aimed at identifying implementation strategies for nutritional management of advanced CKD.
Detailed description
The recent paradigm on dialysis start suggests that an intention to defer policy should be preferred to beginning dialysis early ("the earliest the best" strategy). This strategy is further supported by the consideration that patient profiles are changing with the increasing proportion of older and higher comorbidity patients. In high comorbidity patients, survival is not necessarily improved by dialysis.
Nutritional care, adapted to each patient's needs and preferences, could in part answer these demands. Indeed, renal function has a strict correlation with dietary patterns. Low protein diets may have two favourable effects: 1) slowing down kidney function decline and 2) delaying the need of replacement therapy (metabolic stabilizing). In dialysis, the nutritional state is the most important survival indicator, and nutritional follow-up should allow starting dialysis in a good nutritional status.
The study proposed here is an implementation study with a principal aim to improve the use of low protein diets in the clinical setting, by offering a multiple choice approach and by adapting the diets to the patients' needs.
Interventions
- Other low protein diet
Patients will be managed with a restricted protein intake (controlled protein diets with a mean target at 0.6 g / kg / day of protein, according to a choice of dietary approaches, adapted to the situation of each patient).
Primary outcome measures
- Adherence to the multiple-choice diet program [Time frame: 4 years]
Secondary outcome measures (6)
- Kidney survival [Time frame: 4 years]
- Patient survival [Time frame: 4 years]
- Cost of the treatment [Time frame: 4 years]
- Patients included in a transplantation program [Time frame: 4 years]
- Patients included in a home dialysis program [Time frame: 4 years]
- Patients included in an incremental dialysis program. [Time frame: 4 years]
Eligibility criteria
Inclusion criteria
- All adult patients followed on the unit for advanced CKD, with Kidney disease stage 4-5 or stage 3 with fast progression and without contraindications.
Exclusion criteria
- Malnutrition or short life-expectancy
- Patients aged less than 18 years old
- Pregnant women,
- Incapacity to complete the free-consent form,
- Pateints refusing participation in the study,
- Patients without healthcare coverage.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 2 centers
- Pôle Santé Sarthe et Loir — La Flèche
- Centre Hospitalier Le Mans — Le Mans
Identifiers
NCT: NCT03979534 · CHM-2016-S8/05